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A revolution in treatment for the 3 million people in the U.S. chronically infected with liver-damaging hepatitis C has driven doctors to take unusual steps to speed patient access to emerging and expensive therapies.
Hepatitis C is the leading cause of liver cancer and liver transplants. The current treatment a mix of injectable medicines and a pill can take months and cause debilitating, flulike symptoms.
But two drugs approved in late 2013 by the Food and Drug Administration (FDA), and another soon to be considered for approval, are expected to act faster, be easier on patients and bump the cure rate from about 70 percent to 90 percent, said Utah liver specialist Michael Charlton, medical director of Intermountain Medical Center's Liver Transplant Program.
"When I say cure I mean it never comes back," he said. "The virus is gone unless you get re-infected. … By 2015 there's every indication there will be a single pill that will cure almost everyone."
Charlton, formerly of the Mayo Clinic, was among 27 experts nationally who, anticipating FDA approval of the new drugs, rushed to publish preliminary treatment guidelines for clinicians.
The guidelines, sponsored by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases, don't carry the same weight as those vetted over time by medical journals.
But they may help convince insurers to cover the new treatments and give nonspecialists greater comfort in prescribing them, said Charlton.
"We were worried about people having access to treatment," he said, citing a federal survey showing only 50 percent of those diagnosed with chronic hepatitis C get treatment. "There's a shortage of liver specialists in this country and treatment is complicated enough that there's concern about getting it right."
Publicly available online at http://www.HCVguidelines.org, the guidelines could also prove a useful educational tool for patients, he said.
They don't touch on cost or dictate which patients are candidates for the new drugs. Those details will be added later, Charlton said.
Because only 15 percent of hepatitis C patients get cirrhosis of the liver and become candidates for a transplant, "you could make a case for a wait-and-see approach with some patients," said Charlton. "I'm not advocating that, but I recognize it's a balancing act. We need to at least think about the cost-benefit of these things."
Patient groups have accused Gilead Sciences Inc., maker of sofosbuvir, and Janssen Therapeutics, maker of simeprevir, for overpricing their medicines, which Charlton said average $150,000 for a full regimen.
He, too, wishes they were more affordable for patients, but stressed he's grateful they were developed.
"We tend to see drug companies as Darth Vader-ish … but if you take away advances developed by private industry it's a very different landscape. We'd be looking at a 12 percent cure rate for hepatitis C," he said.
Charlton believes debates over the appropriateness of treatments are best left to medical experts armed with data. "You really need an independent panel to come together to put forward recommendations free of conflicts."
SelectHealth, the insurance arm of Charlton's employer Intermountain Healthcare, is still weighing whether to cover the new hepatitis C drugs. But he says, "I met with them and … I'm confident they will accept these guidelines."
About hepatitis C
Rates of hepatitis C, a chronic viral infection, are lower in Utah than in other states. But it remains a leading cause of cirrhosis and liver transplants. It is one of several hepatitis viruses, including A, B, D and E, but considered to be the most serious.
The current standard of care involves weekly injections of interferon and an oral antiviral drug. Treatment therapies can last several months and have serious side effects.
New therapies interfere with the viruses' ability to replicate, have far fewer side effects, promise to shorten treatment and significantly improve cure rates.
Sources: Utah Department of Health and liver specialists.